Sirtex Germany Manufacturing G M B H

FDA Filings

This page includes the latest FDA filings for Sirtex Germany Manufacturing G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3013070673
FEI Number3013070673
NameSirtex Germany Manufacturing GmbH
Owner & OperatorSirtex Medical Pty Ltd
Contact AddressShop 6 207 Pacific Highway
St Leonards AU-NSW New South Wales 2065 AU
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressIndustriepark Hoechst, Building G808
Frankfurt am Main, 65926 DE
Establishment Type
  • Repack or Relabel Medical Device
  • Manufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
SIR-Spheres2007-10-23
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
SIR-Spheres microspheres2007-10-23
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
SIR-Spheres Delivery Box2003-12-19
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
SIR-Spheres V-Vial Holder2003-12-19
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
Syringe Shield2003-12-19
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
V-Vial2003-12-19
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
SIR-Spheres V-Vial2003-12-19
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
SIR-Spheres Delivery Set2003-12-19
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
SIR-Spheres Accessories Pack2003-12-19

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